ISMP Explores Top Medication Safety Issues of 2018

Given their crucial role in promoting and ensuring medication safety, pharmacists must remain educated about common medication errors and ways to prevent them, according to the Institute for Safe Medication Practices (ISMP).

During a session at the 2018 American Society of Health System Pharmacists (ASHP) Midyear Clinical Meeting, ISMP medication safety specialist Christina Michalek, RPh, presented the organizations’ annual review of the year’s biggest medication safety issues.

Safety issues highlighted by Michalek during the sessions included:

1. Drug Allergy Interactions

Michalek described an incident in which a patient with a documented penicillin allergy was prescribed amoxicillin clavulanate. Alerts notifying the pharmacy team to the allergy was bypassed, and the medication was dispensed, leading to the patient experiencing difficulty breathing.

Alerts like this one are sometimes overridden when it is unsafe to do so, Michalek said.

Potential solutions to this issue include improvements in alerting mechanisms and allergy documentation, as well as continuous alert monitoring and more thorough patient engagement.

2. Investigational Medications

In the past year, several errors and hazards related to investigational drugs have been reported to ISMP. Many of these events were related to labeling, nomenclature, and packaging.

Regulatory guidance for investigational drug labeling, is limited, Michalek said.

However, both the ASHP and the Hematology/Oncology Pharmacy Association have developed their own sets of guidelines for investigational medication, while the Joint Commission has required safe management for the review, approval, supervision, monitoring, storage, and labeling of these drugs.

3. Label and Packaging Problems

According to Michalek, safety issues with drug labels and packaging reported in 2018 involved:

• Cluttered labeling
• Dangerous abbreviations
• Highly stylized label graphics
• Inadequate prominence of reminders and warnings
• Inconsistent and unclear expressions of strength
• Lack of contrast on glass ampules
• Overemphasis on company logos and name

Given the various problems associated with inconsistent labeling practices, the FDA and International Safety Network have spearheaded international efforts to improve medication safety by standardizing design elements, labeling, and packaging. Additionally, the ISMP has recommended that the FDA develop guidance on standard labeling.

4. Vaccine Errors

There are a number of contributing factors associated with vaccine errors, including knowledge-related factors (incomplete vaccination history, unfamiliarity with the product), practice-related factors (failure to verify patient information, miscommunication of order or due date), and product-related factors (age-dependent formulations of the same vaccine, similarly labeled or named vaccines), according to data from the ISMP's National Vaccines Error Reporting Program.

To avoid future errors, the ISMP recommends that providers document all information, educate both patients and staff members, establish or examine protocols, optimize vaccine storage, review how vaccines are listed, and verify immunization status.

Acknowledging that further work is needed to improve medication safety in these and other areas, Michalek ultimately emphasized the importance of aligning process and policy with data.

“Medication safety will always be evolving work,” she said. “As new knowledge emerges, we need to dedicate effort towards improving current state processes.”

Reference

Michalek C. ISMP’s top medication safety issues during 2018. Presented at: 2018 ASHP Midyear Clinical Meeting. December 2-6, 2018. Anaheim, California.